Phase I Clinical Protocol for Pre-evaluation of the Safety of BCG-PPD in Tuberculosis Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Tuberculosis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, blinded, single-arm intradermal injection, comparison of similar products on the marketMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The statistician and the blind operators who do not participate in the trial will perform drug blinding,stick the printed drug label on the designated position of each drug according to the blind bottom. After completing the blind programming, the blind bottom will be sealed and handed over to the sponsor. The blind editors shall not participate in other related work of this clinical trial, and shall not disclose to any personnel participating in the trial.Subjects were randomly injected intracutaneously with BCG-PPD test drugs or BCG-PPD control drugs.All subjects, some investigators and other staff participating in the study were kept blind.The investigators designated in the study to extract drugs are non-blind personnel, and are not allowed to disclose the subject's grouping and skin test information to others, nor are they allowed to participate in any other procedures in the trial.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Younger than 65 years
- Gender
- Both males and females
Description
Prior to the commencement of the study, the Investigator/his authorized officer will contact the subject and/or guardian to enroll the candidate subjects and invite them to participate in the study.Subjects who are eligible for screening receive the drug number in the order they arrive at the random...
Prior to the commencement of the study, the Investigator/his authorized officer will contact the subject and/or guardian to enroll the candidate subjects and invite them to participate in the study.Subjects who are eligible for screening receive the drug number in the order they arrive at the random number allocation room.They have to undergoing physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, chest X-ray, tuberculosis culture, tuberculosis smear, HIV antibody test and blood pregnancy?only women of childbearing age? during the screening period. Inverstigator absorb and inject 0.1ml drug into the upper and middle 1/3 of the left forearm by Mondo's method. The reaction of the injection site was checked and photographed at 0min, 48h and 72h after the skin test. Meanwhile, the transverse and longitudinal diameers of skin induration and redness were measured at 48h and 72h after the skin test.Vital signs are checked at 30min after skin test.Vital signs examination, injection site photography and reaction measurement are performed 48h and 72h after skin test.Physical examination, vital signs, routine blood test, routine urine test, biochemical test, electrocardiogram and blood pregnancy test are performed again 7 days after skin test.All AE occurred within 7 days after skin test were recorded by a diary card. AE related to the test drug should be followed up to the end of the event.Skin test of subjects aged 18-45 years shall be conducted first. After safety assessment, skin test of subjects aged 46-65 years old, 6-17 years old and under 6 years old shall be conducted successively.
Tracking Information
- NCT #
- NCT04538911
- Collaborators
- Shenzhen Third People's Hospital
- Beijing Kangterike Statistical Technology Co., Ltd.
- Investigators
- Principal Investigator: Zhongyuan Wang, Master Shenzhen Third People's Hospital
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